📋 FDA Reference
Winged Fistula Needle
Gambro
Summary: The winged fistula needle is a medical device used primarily in dialysis settings to access a patient's vascular system. It is commonly used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K760935 ↗
Decision Date ?
November 19, 1976
Product Code ?
KOC
Device Class ?
Class 2
Evidence ?
0 studies
The winged fistula needle by Gambro was cleared through the FDA 510k pathway on November 19, 1976. It is classified as a Class 2 device under product code KOC.
What It Is
The winged fistula needle is a specialized needle designed for vascular access in patients undergoing dialysis. It features a winged design that allows for easier handling and stabilization during insertion. The needle is typically used to connect the patient's blood circulation to the dialysis machine, facilitating the removal and return of blood during treatment.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Accessing surgically created arteriovenous fistulas or grafts.
Clinical Applications
- Cannulation of an arteriovenous fistula for hemodialysis.
- Cannulation of an arteriovenous graft for hemodialysis.
- Establishing blood flow from a dialysis access to the extracorporeal dialysis circuit.
- Returning dialyzed blood to the patient's vascular access during a hemodialysis treatment.
Practical Considerations
- Available needle gauges and lengths should be selected according to the access anatomy, prescribed blood-flow rate, and dialysis protocol.
- The wings help with handling and stabilization, but the needle must be placed and secured using appropriate dialysis-access technique.
- Use requires compatibility with the dialysis blood tubing and machine circuit.
- Potential complications include infiltration, hematoma, bleeding, infection, thrombosis, and injury to the vascular access.
- MRI safety depends on the specific needle and packaging. A needle should not be assumed to be MR safe or MR conditional without manufacturer labeling; it is normally removed after dialysis access use.
Related Literature
The linked study focused on the use of bipolar diathermy in distal hypospadias repair, not directly related to the winged fistula needle. However, it highlights the importance of precision tools in surgical procedures. The study found that bipolar diathermy was effective for dissection, but the findings are limited to a specific surgical context unrelated to dialysis.
Frequently Asked Questions
What is the winged fistula needle used for?
It is used for vascular access in hemodialysis, connecting the patient's blood circulation to the dialysis machine.
What specialties typically use this device?
Nephrology and dialysis nursing are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring hemodialysis, specifically for accessing arteriovenous fistulas or grafts.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.